FDA announced that it would delay guidelines on digital marketing until end of Q1 2011. You can read up on it over on Advertising Age here.
Now, much of the attention to this matter – the concerns about Adverse Event reporting, Fair Balance, HIPAA, etc. – has focused on getting FDA to offer guidance on how the regulated life sciences industries can participate in 21st Century media.
It’s a huge issue, fraught with all sorts of nuances (do we need FDA-compliant tweets for goodness sake?) and under-the-hood considerations (data in sharing widgets, etc.).
FDA could go anywhere with this matter. There’s been debate if FDA even fully understands the properties of emerging media and how they all inter-relate. FDA could set a very tight leash on marketing – which would also limit the industry’s ability to interact with patients in ways that could be beneficial.
But one scenario which I’m not sure has been pointed out. What if FDA went in an almost opposite direction. What if FDA actually said to the industry:
We want you to have social media presences so that you can monitor for Adverse Events, track conversations about your products and be immediately available on social networks in cases of public health emergencies.
Furthermore, what if FDA mandated that companies collect, document and store all tweets, blog posts, Facebook status updates and all other public communications?
And not only company-generated communications, but any communications to the companies (e.g. mentions on Twitter). And that the databases be readily subject to audit.
It’s just a thought.
I can’t imagine FDA going this way without at the same time putting a leash on what companies can do.
So what if the following happens? Pharma gets the craziest of both worlds: a mandate to establish digital presences while being limited in what it can actually do. o_O
I don’t know. My sense is that the whole project will be a mess.
The more you think about these peculiar regulatory problems – the deeper you think about all the nuances – you realize how twisted the Web is making things.
Maybe what’s needed isn’t so much social media guidance.
Maybe what’s needed is an entirely different model of regulation: a different regulatory agency, a different Pharma marketing mindset and a better way to deliver molecular and mechanical solutions to human health problems.
Yeah, looks like the Web done gonna ruin a long drug party.